Ivy Sports Medicine, LLC
United StatesFDA applicant, unverified
- Devices
- 9
What Ivy Sports Medicine, LLC makes
Ivy Sports Medicine, LLC manufactures meniscus implants, including the IvyAIR Meniscus System in curved, straight, and reverse curved designs, as well as the Collagen Meniscus Implant XL. These devices are intended for meniscus repair or replacement in orthopedic surgery.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved Ref K153087
Regimes: 510(k) Registry: 510(k)Collagen Meniscus Implant XL Ref K170364
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 046226406
- [email protected]
- Phone
- 1-800-624-4422
Frequently asked questions
How many devices does Ivy Sports Medicine, LLC have in the registry?
The registry currently lists 9 devices for Ivy Sports Medicine, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ivy Sports Medicine, LLC's devices?
Among its 9 most recently registered devices, Ivy Sports Medicine, LLC has devices listed in FDA 510(k) (2 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ivy Sports Medicine, LLC's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Ivy Sports Medicine, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ivy Sports Medicine, LLC in the registry?
The most recently registered devices listed for Ivy Sports Medicine, LLC include IvyAIR Meniscus System, Curved 4730, Collagen Meniscus Implant CMI® Medial XL, SharpShooter® Surgical Suture HS4704 and Collagen Meniscus Implant CMI® Medial 7.5 mm.